This study is to allow continued access to QTI571 for patients who received QTI571 for pulmonary arterial hypertension in one of the long-term extension studies (A2301E1, A2102E1 and E2203) and have been judged by the investigator to benefit from continued QTI571 treatment.

An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in one of the extension studies and are judged by the investigator to benefit from continued QTI571 treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001100-10-ES

Enrollment

Registered

2013-11-12

Start date

2013-11-12

Completion date

Unknown

Last updated

2013-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension MedDRA version: 16.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: GLIVEC 100 mg comprimidos recubiertos con película Product Name: Imatinib mesilate Product Code: QTI571 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IMATINIB MESILATE CAS N

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient is receiving QTI571 for the treatment of PAH and is currently enrolled in a longterm extension study (CSTI571E2203, CQTI571A2301E1, and CQTI571A2102E1). 2. Patient is currently benefitting from the treatment with QTI571 in the opinion of the investigator. 3. Written informed consent must be obtained prior to enrolling into the QTI571A2314 study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 67 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14

Exclusion criteria

Exclusion criteria: 1. Patient has been permanently discontinued from QTI571 study treatment in the parent extension study. 2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 3. Concomitant use of oral vitamin K antagonist medication.

Design outcomes

Primary

Measure	Time frame
Main Objective: To provide continued treatment to PAH patients who are benefitting from treatment with QTI571;Secondary Objective: To collect long term data on serious adverse events.;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Australia, Spain, Switzerland, United States

Contacts

Public ContactDepartamento Médico (ICRO)

Novartis Farmacéutica, S.A.

eecc.novartis@novartis.com34900353036

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026